FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.
FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist.
FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.
FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist.
FDA accepts for review a Teva Pharmaceuticals NDA for ecopipam, indicated for treating pediatric patients with Tourette syndrome.
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, including personalized cancer immunotherapies, vectored products and cell-based therapies.
